S 1082 MAJOR THREAT TO HEALTH FREEDOMS

[Guest guest]

Moderator's Note: Why do we want any regulations at all? Has it done the AMA

any good to be regulated?

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CALL YOUR US REPS AND SENATORS AND PROTEST THIS BILL !!!

 

NewsTarget is reprinting, with permission, an article published

today by Byron Richards, author of Fight for Your Health: Exposing

the FDA's Betrayal of America. In this article, Richards exposes the

real story behind a little-known provision in the new Food and Drug

Administration Revitalization Act (S1082), which has already passed

a Senate subcommittee and is headed for an eventual floor vote.

 

This Revitalization Act, it turns out, seeks to create a new

government-run pharmaceutical company headed by officials from the

FDA. It would officially and unambigiously put the U.S. government

in the drug business, where it could license pharmaceuticals and

collect royalties on their sale. For obvious reasons, this is a

particularly dangerous situation for consumers. Government should be

regulating drug companies, not joining them as partners in profit.

 

Specifically, the proposed Reagan-Udall Foundation for the Food and

Drug Administration, which will be operated by FDA personnel,

will: ...award grants to, or enter into contracts, memoranda of

understanding, or cooperative agreements with, scientits and

entities, which may include the Food and Drug Administration,

university consortia, public-private partnerships, institutions of

higher education, entities described in section 501©(3) of the

Internal Revenue Code... and industry, to efficiently and

effectively advance the goals and priorities established under

paragraph (2). (Link to source documented included below.)

 

Paragraph 2 says: (2) Establish goals and priorities in order to

meet the unmet needs identified in paragraph (1).

 

Paragraph 1, in turn, says: (1) Taking into consideration the

Critical Path reports and priorities published by the Food and Drug

Administration, identify unmet needs in the development,

manufacture, and evaluation of the safety and effectiveness,

including postapproval, or devices, including diagnostics,

biologics, and drugs, and the safety of food, food ingredients and

cosmetics.

 

In other words, the Reagan-Udall Foundation squarely puts the FDA in

the business of entering into contracts with private industry for

the manufacture of drugs. That's only the beginning of this story.

 

Here is the full text from Byron Richards:

 

 

Perverse Expansion of FDA Powers Will Target Dietary Supplements

by Byron Richards

 

A new attack against health freedom, drug safety, and dietary

supplements was launched last week by Senator Edward Kennedy (D-MA)

with major support from Michael Enzi (R-WY). It is called the Food

and Drug Administration Revitalization Act (S1082). This legislation

was planned over the past few years working hand-in-glove with the

FDA's dysfunctional management and legal team – meaning this

legislation was written for the profits of Big Pharma and Big

Biotech AT THE EXPENSE OF SAFETY AND HUMAN HEALTH.

 

S1082 is a Trojan Horse bill that pretends to address safety issues.

Unbelievably, the bill turns the FDA into a drug development company

that will expose Americans to new and dangerous biological drugs

that have little testing to prove safety or effectiveness. And to

top it off, the bill gives broad new regulatory powers to the FDA

that can be used to frivolously attack dietary supplements and

forward the FDA management's anti-American globalization agenda.

 

On April 18, 2007, S1082 was approved by the HELP committee (which

Kennedy and Enzi control) and now moves to the floor of the Senate.

In a slick move, Kennedy has attached his long-planned FDA/Big

Pharma " reform " measures to the renewal of Prescription Drug User

Fee Act (PDUFA). Current PDUFA law expires later this year and must

be reviewed by Congress. PDUFA allows Big Pharma to pay the FDA fees

to speed the approval of its drugs. The new Kennedy bill will

increase these FDA bribes to 380 million dollars in 2008, well over

50% of the FDA budget for new drug approvals. This is like paying

the mob for protection. Kennedy, by replacing the existing PDUFA law

with this new bill (S1082), is ensuring that his twisted legislation

is the one that will be put before the Senate for a vote.

 

 

The FDA Drug Company, an Agency with New Regulatory Power

It is hard for anyone to comprehend that the agency that is supposed

to be in charge of drug safety is about to become a drug company. It

is astonishing that the FDA will now manage a full scale business

activity that uses a " non profit " foundation as a shield to avoid

international patent problems, protect proprietary rights of its

commercial drug-development enterprise, and massively expands FDA

regulatory powers to quickly remove anything from the market that is

competition to its own products and licensing agreements.

 

This new FDA business enterprise is called the Reagan-Udall

Foundation for the Food and Drug Administration (see pages 105-125).

In previous versions of the Kennedy bill it was going to be an

independent drug company within the FDA (the Reagan-Udall Institute

for Applied Biomedical Research). In the current bill it is a " non

profit " collaboration of the FDA, private industry, government

funding, and private funding. It is run directly by the FDA even

though it pretends to not be part of the government. Under this scam

taxpayers will foot the bill for drug development and then be

charged outrageous prices for the drugs. Furthermore, the new bill

seeks to allow a massive expanse of FDA regulatory power through

this new foundation. For example, on pages 106-107 the bill states:

 

" The purpose of the Foundation is to advance the mission of the Food

and Drug Administration to modernize medical, veterinary, food, food

ingredient, and cosmetic product development, accelerate innovation,

and enhance product safety….The Foundation shall [take] into

consideration the Critical Path reports and priorities published by

the Food and Drug Administration, identify unmet needs in the

development, manufacture, and evaluation of the safety and

effectiveness, including post approval, of devices, including

diagnostics, biologics, and drugs, and the safety of food, food

ingredients, and cosmetics. "

 

Through this foundation the FDA is seeking broad new regulatory

power that it currently does not possess. This will include the

authority to attack any dietary supplement (which are food

ingredients) as unsafe based on its use of " Critical Path "

technology. This means the FDA will use proteomics (the advanced

study of proteins in biological systems) to assess changes in

biomarkers (the change in the state of a protein at the molecular

level) in order to establish whatever it wants to consider as a

risk. The FDA can slant this technology, based on their own personal

opinions, to make anything they want appear as a risk – including

your favorite dietary supplements that you use to stay healthy.

 

 

Deceiving the Public

This new bill panders to concerns of Americans regarding the safety

of drugs. This legitimate worry is used by Kennedy and Enzi to

garner support when in reality the bill does just the opposite -

exposing Americans to almost unfathomable new drug risks and dangers

while simultaneously making it possible to remove super safe,

therapeutic, and helpful dietary supplements. The entire Critical

Path initiative is a plan to race new and untested powerful

biological drugs onto the market and experiment on patients all over

the country – throwing caution to the wind as far as drug safety is

concerned.

 

While S1082 also pretends to address the issues of drug safety, in

reality all the needed Big Pharma loopholes are firmly in place.

Additionally, the establishment of a clinical trial database as

written in this proposed law will enable Big Pharma to hide

experimental and undesirable side effects. Instead of full

disclosure we will have a sterilized clinical trial database that

will have the net effect of being used as a tool by Big Pharma to

promote off label use of drugs. This is a far cry from disclosure

that results in safety.

 

In response to the Kennedy con Charles Grassley (R-IA) immediately

attacked the legislation on the floor of the Senate:

 

" The bill [s1802] does not address the outstanding critical problem

that the office responsible for post-market drug safety lacks the

independence, lacks the authority to promptly identify serious

health risks and take necessary steps that will protect the public.

As I think we all agree, the FDA is in desperate need of major

overhaul. "

 

The problem for Grassley, and all Americans, is that his true safety

reform measures for the FDA are being held hostage by the HELP

committee which is under the control of Kennedy and Enzi. His

proposed legislation is S. 468: Food and Drug Administration Safety

Act of 2007 and S. 467: Fair Access to Clinical Trials Act of 2007.

As Grassley told the Senate:

 

" Let me be clear: Big Pharma does not like these bills. FDA

management does not like these bills. Lobbyists are spending hours

upon hours lobbying against these bills…What is wrong with

establishing a separate center within the FDA--not outside the FDA,

within the FDA--with its only job being that of a watchdog for those

drugs already in the market?...What is wrong with supporting a

clinical trial registry and results database that also requires

sponsors to reveal their negative trials?...I propose there is

nothing wrong with any of these proposals. "

 

The situation is rather grave for all Americans. Kennedy has

attached repressive legislation to replace the PDUFA funding thereby

ensuring that his agenda will come before the Senate for a vote. The

only real opposition to the legislation is coming from Grassley, who

is attacking the weakness in FDA reform regarding drug safety and

clinical trials. An even greater threat to the public – turning the

FDA into a drug company and creating new regulatory powers that can

be used to attack dietary supplements and remove them from the

market – is being ignored by everyone – until now. Kennedy knows he

can defeat Grassley and keep Grassley's bills from ever seeing the

light of day. Can Kennedy defeat the American public? Solving this

problem is up to you.

 

 

The Secret FDA Agenda – Government Against the People

The FDA is a puppet organization. Its management is a revolving door

with Big Pharma, Big Biotech, and Big Agriculture. The behavior of

its management team, set by its current leader Andrew von

Eschenbach – but fully entrenched in its long and ugly history, is

one of acting as a police-force bully to forward the profits of

those with money and stamp out all competition (under the false

guise of consumer protection). The FDA management fully believes it

is above any law that is in its way or any attempt at Congressional

oversight. It gives lip service to its safety mission. It is a cult

unto itself.

 

The anti-American FDA is actively seeking to undermine U.S. laws and

harmonize our dietary supplement laws with Mexico and Canada. This

is being done through the Trilateral Cooperation Charter – an

illegal agreement set up with health regulatory agencies in Mexico

and Canada. It is part of the campaign towards a North American

Union, one which would be a catastrophe for health freedom in this

country as dietary supplement laws in Canada and Mexico are far more

restrictive than in the U.S.

 

The FDA would also like to harmonize our dietary supplement laws

with the evolving international standards set by Codex, thus

branding therapeutic nutrition as dangerous and risky and needing to

be sold by Big Pharma or removed from the market altogether (if it

competes with a blockbuster category of drugs). Codex is planning to

use the same proteomics and biomarker technology that will be used

by the FDA's Critical Path Initiative to remove therapeutic dietary

supplements from the international market and force their policies

on America, thereby superseding the sovereignty of American law on

threat of trade sanctions. The FDA fully supports draconian Codex

guidelines to regulate dietary supplements and is working with the

Germans to concoct technology to brand nutrients as drugs. The FDA

management is as bad as any government agency can get. Under the

leadership of Andrew von Eschenbach it has plummeted to an all time

low.

 

 

What You Can Do Now:

1. Call, fax, phone, and write your Senators and tell them you are

opposed to bill S1082 - Food and Drug Administration Revitalization

Act. Tell them you want no legislation of any kind that will enable

the FDA to frivolously attack dietary supplements. Tell them you do

not want Big Pharma funding the FDA with user fees for drug

approvals. Demand an independent office within the FDA to monitor

drug safety. And tell them you want full disclosure by Big Pharma of

all their clinical trials. Tell them you support the Grassley

legislation (S467 and S468) which offers true reform of the FDA.

Click here for sample letter.

 

2. Tell your Senators you are completely opposed to any law that

would enable the FDA to act as a drug company, such as S1082, which

is proposing the formation of the Reagan-Udall Foundation for the

FDA. Click here for sample letter.

 

3. Sign this petition demanding congressional oversight of the FDA's

Trilateral Cooperation Charter – a key point the FDA is using to

illegally support the formation of the North American Union while at

the same time undermining health freedom. This is the FDA's front

line attack that undermines American law and seeks to harmonize us

with the laws of other countries. We must win this battle to stop

Codex and preserve our health freedom – including access to

therapeutic dietary supplements and all alternative health options.

 

If S1082 becomes law and the FDA is allowed to enter relationships

with foreign countries without any Congressional mandate or

oversight we can kiss health freedom goodbye – as well as our

dietary supplements. It is time for dietary supplement companies and

trade groups to get their heads out of the sand and quit jockeying

for position in the New World Order at the expense of the future

well being of their own customers.

 

The issue of health freedom is an issue for all Americans who

believe in our constitution and our founding documents. America is

the last bastion of health freedom on earth. If we fall, the world

will be plunged into a Dark Ages of health. Our future health will

be dictated by a multinational sickness industry driven by profits

for drug and biologic companies with little to do with real quality

of health. This is a crossroads – a moment in time. Health freedom

is fundamental to all other freedoms as without health freedom the

minds and bodies of a population are easy to control.

 

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2007 Truth In Wellness, LLC .

Reprinted with permission.

 

Byron J. Richards, Founder/Director of Wellness Resources, is a

Board-Certified Clinical Nutritionist and nationally-renowned health

expert, radio personality, and educator. He is the author of

Mastering Leptin, The Leptin Diet, and Fight for Your Health:

Exposing the FDA's Betrayal of America.

 

Richards encourages individuals to take charge of their health,

stand up for their health rights, and not blindly succumb to

propaganda from the vested-interests who profit from keeping

Americans sick.